MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY; ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP

Model Number	1000096
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the customer was hospitalized multiple times; details and nature of event were not provided.Reportedly, the customer alleged that pump was "failing".Multiple attempts were made by tandem technical support to follow-up with the customer on the reported issue, but no response was received.

• Brand Name: T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
• Common Device Name: ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP
• Manufacturer (Section D): TANDEM DIABETES CARE; 12400 high bluff drive; san diego CA 92130
• Manufacturer Contact: john connell ; 12400 high bluff drive; san diego, CA 92130 ; 858 224-6281
• MDR Report Key: 25732932
• Report Number: 3013756811-2026-120596
• Device Sequence Number: 18745113
• Product Code: QFG
• UDI-Device Identifier: 00853052007264
• UDI-Public: (01)00853052007264
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K201214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1000096
• Device Catalogue Number: 1000886
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Male